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I am moderating a round table discussion on "How to face and
successfully defend FDA inspections and other regulatory Audits" on
Nov 10, 2009 between 9.00 -11.00 am as part of the 2009 AAPS annual
meeting in Los Angeles. During this round table discussion we would
like to get an insight on different steps on the preparedness in
facing various regulatory audits, how to plan various face to face
meetings (pre-IND, IND, end of phase II etc.) and successfully
negotiate the meeting outcome. There is nothing like a magic bullet
therefore it is a good idea to hear from the experiences of prominent
speakers from FDA, CRO and Industry experience during this round table
This is an open floor model discussion encouraging active engagement
of everyone experience. If you want any questions or issues to be
discussed, please forward the questions in advance to my attention
via e-mail: drprasadtata.-at-.yahoo.com so that I will try to cover all
questions received in advance.
Hoping to hear from you soon.
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